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Also known as BXCL501 Sublingual Film
BXCL501 Film · 1 trial · 6 indications
The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The informant-completed questionnaire (modified clinical global impression of severity for informants (mCGI-S-INF) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-INF is a single item with a 0 to 3 point scale with higher values indicating more severe agitation. The PEC is a five item questionnaire with 7-point response options, overall scores range from 5 to 35 with higher scores indicating more severe agitation.
Assess content validity of the Modified Clinical Global Impression of Severity for Informants (mCGI-S-INF) and informant training materials. The scale being utilized is mCGI-S-INF. There is no score as it is a qualitative assessment and it is being validated to measure patient informant reported outcomes against patient reported outcomes (mCGI-S-PAT) and physician reported outcomes using the Positive and Negative Syndrome Scale - Excited Component (PEC) scale where the highest score indicates the maximum agitation that could be experienced.
| Arm | Type | Description |
|---|---|---|
| BXCL501 Sublingual film | EXPERIMENTAL | Experimental: 120 mcg of BXCL501 Sublingual film containing 120 Micrograms Dexmedetomidine |
| Name | Type | Description |
|---|---|---|
| BXCL501 Sublingual Film | DRUG | Single dose BXCL501 120 mcg |
Inclusion Criteria for Participant: 1. Male and female patients 18 to 75 years old, inclusive. 2. Patients who can read, understand, and provide written informed consent. 3. Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, v5, Text Revision (DSM-5-TR) criteria for a prim...
Top 10 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 4 | PHASE3 | Xanomeline and trospium chloride, Xanomeline/Trospium Chloride |
| AbbVie, Inc. | ABBV | 3 | PHASE3 | Cariprazine, ABBV-932, Icalcaprant |
| Xenon Pharmaceuticals Inc. | XENE | 2 | PHASE3 | Azetukalner |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Rapport Therapeutics, Inc. | RAPP | 1 | PHASE2 | RAP-219 |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE2 | NBI-1117568 |
| Alto Neuroscience, Inc. | ANRO | 1 | PHASE2 | ALTO-100 |
| LB Pharmaceuticals, Inc. | LBRX | 1 | PHASE2 | LB-102 |
| BioXcel Therapeutics, Inc. | BTAI | 1 | PHASE1 | BXCL501 |
| Alzamend Neuro, Inc. | ALZN | 1 | PHASE1 | AL001 |
BXCL501 Film is being developed for the treatment of acute psychomotor agitation associated with bipolar I disorder. It is an investigational sublingual film formulation that is placed under the tongue. BioXcel Therapeutics is studying it in adults aged 18 years and older.
BXCL501 Film is being developed by BioXcel Therapeutics, Inc., which trades on the Nasdaq under the ticker BTAI. The company is responsible for the clinical development of the sublingual film formulation for agitation associated with bipolar I disorder.
BXCL501 Film is in Phase 2 clinical development. The completed Phase 2 trial, NCT07116694, evaluated acute psychomotor agitation measures associated with schizophrenia and bipolar disorder. The trial enrolled 33 participants and was conducted in the United States.
BXCL501 Film has been studied in one completed Phase 2 trial, NCT07116694, titled Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder. The trial enrolled 33 adults and included conditions such as bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, and schizophreniform disorders.
Yes, BXCL501 Film and BXCL501 Sublingual Film refer to the same investigational product. BXCL501 Sublingual Film is an alternative name for the sublingual film formulation being developed by BioXcel Therapeutics for acute psychomotor agitation associated with bipolar I disorder.
BXCL501 Film has received Fast Track designation from the FDA. Fast Track is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. The drug remains investigational and is in Phase 2 clinical development.